FDA-approved drugs are provided in many different forms based on the type of active substance, the indication treated and the preferred route of administration. These forms include enteral formulations (e.g., tablets, capsules or pills), parenteral formulations (e.g., injectable formulations such as intravenous, subcutaneous, intramuscular and intraarticular), liquid formulations (e.g., elixirs), lyophilized formulations and topical formulations. A majority of the FDA-approved drugs are currently available in enteral form, as either a tablet or capsule.
Several formulations have been investigated for deterring abuse, either by oral ingestion of the drug with alcohol, or by non-oral administration routes such as intranasal and/or intravenous administration. For example, U.S. 2014/0010873 (assigned to Egalet Ltd.) is directed to an abuse-deterrent pharmaceutical composition including at least one polyethylene oxide and at least one plasticizer. The polyethylene oxide has an average molecular weight of at least 1,000,000 Daltons, and the pharmaceutical composition includes at least 5 percent w/w of the at least one plasticizer. The pharmaceutical composition is designed to prevent immediate release of the at least one active drug substance after physical tampering. U.S. 2009/0123386 (assigned to MW Encap Limited) is directed to an abuse deterrent capsule including at least one modifier selected to prevent abuse. The modifier may have a high melting point or be insoluble in aqueous solvents or ethanol. For example, the high melting point excipient may be Poloxamer 188 or PEG 8000. U.S. 2010/0204259 (assigned to Egalet A/S) is directed to immediate release pharmaceutical compositions that are resistant to abuse by intake of alcohol. The release of the drug substance from the immediate release composition is decreased when the composition is exposed to a dissolution medium that includes ethanol. The compositions may be formulated to include at least one polyglycol and at least one effervescent agent.